| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 02, 2026 |
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| Date Posted | October 15, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0173-2027 |
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| Recall Event ID |
99886 |
| Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
| Product | Medline surgical convenience kits labeled as:
1) EAR, Medline product number/SKU DYNJ909020B;
2) EAR, Medline product number/SKU DYNJ909020A;
3) CAROTID PACK, Medline product number/SKU DYNJ42922C;
4) EAR, Medline product number/SKU DYNJ909020;
5) FEM CAROTID PACK, Medline product number/SKU DYNJ65706;
6) CAROTID CDS-LF, Medline product number/SKU CDS983139B. |
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| Code Information |
Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 26AMF311;
Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25JMD500;
Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25DMJ849;
Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25CMD823;
Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25BMG250;
Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 24LMG633;
Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24KMB736;
Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24JMD634;
Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24IMD605;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBT243;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBD143;
Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24GMG103;
Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24DMI379;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24CBJ928;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24BME929;
Medline product number/SKU DYNJ65706, UDI/DI 10193489284904 (each) 40193489284905 (case), Lot number 24AMF210;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24AMD338;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LME666;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LMB230;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMF895;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMD188;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23HMH838;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23HBG421;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23FBD203;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23EBL260;
Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23CMB011;
Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23CBU833;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBV592;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBJ850;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22ABL217;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21LBM269;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21HBC597;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21GBE864;
Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21FBJ082.
|
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield
IL
60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 9/2/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following:
"REQUIRED ACTION:
1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.
2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.
Website link: https://recalls.medline.com, Recall Reference #: R-26-201-FG, Recall Code:
3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable."
Those consignees who further distributed the product were directed to notify the parties to whom the affected product was distributed.
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 620 kits |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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